Regulatory Intelligence
Per-ingredient regulatory status across 21 markets. Updated. Structured. Queryable.
theformulator.ai holds per-ingredient regulatory status — prohibited, restricted with a concentration ceiling, or permitted — across 21 cosmetic markets, derived from each jurisdiction's primary regulatory text and traceable to the regulation and annex. A separate drug–cosmetic boundary layer covers 9 markets and 82 thresholds, each classified by the trigger that crosses it.
EU Regulation 1223/2009 Annexes. US FDA MOCRA. Japan MHLW Standards. China NMPA. Korea MFDS. India CDSCO and IS 4707. ASEAN Cosmetic Directive. Brazil ANVISA. Australia TGA. Canada Health Canada. Turkey TİTCK. Taiwan TFDA. One platform, every market your product needs to ship.
21-market regulatory coverage
This regulatory intelligence runs behind the formulation generator, the formulation audit, the deformulation tool, and the Formulation Partner AI co-pilot.
For every ingredient in a formulation, we check status across all target markets simultaneously (prohibited, restricted with concentration ceilings, or permitted), pulling from the primary regulatory text for each jurisdiction. No more cross-referencing EUR-Lex Annexes against MHLW positive lists against NMPA inventory against IS 4707 by hand.
Regulatory status is not a single binary flag. A restricted ingredient in the EU may be permitted up to 0.5% in rinse-off products but prohibited in leave-on products. A permitted preservative in Japan may be prohibited at any concentration in products for children under three. These product-type and use conditions are captured per-ingredient, not flattened to a single status.
| Market | Regulatory Body | Key Sources |
|---|---|---|
| 🇪🇺EU | EC Regulation 1223/2009 SCCS Scientific Opinions | Annex II (prohibited) · Annex III (restricted with concentration ceilings) · Annex IV–VI (permitted colorants, preservatives, UV filters with conditions) |
| 🇺🇸US | FDA MOCRA 2022 · OTC Monographs | Prohibited and restricted ingredient lists · Color additive certification · OTC drug monograph actives (sunscreen, acne, dandruff, antiperspirant) |
| 🇬🇧UK | UK Cosmetic Regulation Retained EU law post-Brexit | Mirrors EC 1223/2009 with UK-specific updates. Annex II–VI status maintained separately post-divergence. |
| 🇨🇳China | NMPA IECIC Inventory · Special Cosmetic Categories | Prohibited and restricted ingredient lists · IECIC positive inventory · Special cosmetic actives (sunscreen, hair dye, whitening, antifrosting, hair perm) |
| 🇯🇵Japan | MHLW Standards for Cosmetics · Quasi-drug Standards | Prohibited ingredient list · Restricted ingredient limits · Positive list for preservatives and UV filters · Quasi-drug (医薬部外品) active ingredient standards |
| 🇮🇳India | CDSCO · BIS IS 4707 · Drugs & Cosmetics Act | BIS IS 4707 prohibited and restricted ingredient lists · Drugs & Cosmetics Act Schedule M restricted substances · Drug schedule boundary triggers |
| 🇰🇷South Korea | MFDS Cosmetics Act · Functional Cosmetics Regulation | Prohibited and restricted ingredient lists · Functional cosmetic (기능성화장품) active ingredients requiring registration (whitening, UV, wrinkle, hair loss) |
| 🇨🇦Canada | Health Canada Cosmetic Regulations · NHP Regulations | Hotlist prohibited and restricted substances · Natural Health Product boundary triggers · Drug Identification Number threshold conditions |
| 🇦🇺Australia | TGA · NICNAS/AICIS Industrial Chemicals Act · Therapeutic Goods Act | AICIS industrial chemical assessments · TGA therapeutic goods boundary · Prohibited and restricted substances |
| 🇧🇷Brazil | ANVISA RDC 2024 · Grade 2 Cosmetics | Prohibited and restricted ingredient lists · Grade 2 cosmetic category triggers requiring ANVISA notification or registration before market entry |
| 🇹🇷Turkey | TİTCK · Ministry of Health Kozmetik Yönetmeliği (Cosmetics Regulation) | Prohibited and restricted ingredient lists harmonised with EC 1223/2009 Annexes, with Turkey-specific provisions and effective-date tracking on restriction changes |
| 🇹🇼Taiwan | TFDA Cosmetic Hygiene and Safety Act | Prohibited and restricted ingredient lists · Preservative, colorant, and UV-filter positive lists · Specific-use cosmetic (含藥化粧品) actives requiring registration |
| 🇹🇭Thailand | Thai FDA Cosmetics Act B.E. 2558 | Prohibited and restricted ingredient lists · Controlled cosmetics requiring pre-market notification |
| 🇲🇾Malaysia | NPRA Control of Drugs and Cosmetics Regulations | Prohibited ingredient list · Restricted ingredient list · Notified cosmetic requirements under CDCR |
| 🇸🇬Singapore | HSA Health Products Act | Prohibited and restricted ingredient lists aligned to ASEAN Cosmetic Directive with Singapore-specific provisions |
| 🇮🇩Indonesia | BPOM Cosmetics Regulation | Prohibited and restricted ingredient lists · BPOM registration requirements for certain actives |
| 🇻🇳Vietnam | MOH ASEAN Cosmetic Directive · Circular provisions | ASEAN harmonized prohibited and restricted lists · Vietnamese-specific restricted substances |
| 🇵🇭Philippines | FDA Philippines ASEAN Cosmetic Directive · RA 9711 | ASEAN harmonized lists · Philippines FDA prohibited and restricted substances · Cosmetic notification requirements |
Primary-instrument monitoring across the 21 markets has not yet recorded a run.
Source monitoring table: not yet run.
What backs the regulatory intelligence
Regulatory status for each ingredient is derived from the primary regulatory text, not from third-party summaries, ingredient supplier datasheets, or commercial safety databases. Every status entry is traceable to a specific regulation, article, and annex.
| Source | What we extract | Coverage |
|---|---|---|
| EUR-Lex Annexes II–VI | Prohibited substances (Annex II), restricted substances with maximum concentrations and product-type limitations (Annex III), permitted colorants/preservatives/UV filters with conditions (Annexes IV–VI) | Full EU Regulation EC 1223/2009 Annexes |
| SCCS Scientific Opinions | Safety assessments that drive EU regulatory decisions: ingredient-level opinions used to update Annex status and concentration limits | Referenced per ingredient where applicable |
| FDA CFR Title 21 | OTC monograph active ingredient lists and concentration ranges, prohibited substances list, color additive certification requirements | Parts 700, 720, 740; OTC monograph sections |
| MOCRA 2022 | MoCRA provisions on prohibited ingredients, fragrance allergen disclosure, and mandatory cosmetic facility registration | All provisions effective under MoCRA timeline |
| CIR Safety Assessments | 2,600+ final safety assessment reports: ingredient-level conclusions referenced alongside regulatory status for comparative intelligence | 2,654 assessment reports |
| REACH IUCLID Dossiers | Registered substance dossiers providing study-level toxicology data cross-referenced against regulatory classifications | 26,800+ dossiers, 13.5M+ study endpoints |
| National Positive & Negative Lists | Per-market permitted, restricted, and prohibited ingredient inventories, such as MHLW positive lists (JP), NMPA IECIC (CN), MFDS ingredient lists (KR), IS 4707 (IN), Health Canada Hotlist, BPOM (ID), MOH (VN), and equivalents | 21 market regulatory inventories |
Drug-cosmetic boundary alerting
Regulatory status checking covers the full ingredient list. Drug-cosmetic boundary alerting is a distinct, additional layer: it checks whether a specific combination of ingredient, concentration, and claim crosses from cosmetic classification into drug, quasi-drug, or functional cosmetic territory in each target market.
The boundary is claim-driven, not just concentration-driven
Most formulators approach the drug-cosmetic boundary as a concentration lookup: find the ingredient, find the market, find the maximum allowed concentration, stay under it. For restricted cosmetic ingredients, that is correct. For drug-cosmetic boundaries, it is dangerously incomplete.
The US FDA OTC Drug Monograph system is the clearest example. A sunscreen active such as Octinoxate, Zinc Oxide, Avobenzone, or Homosalate is a cosmetic ingredient. It becomes an OTC drug the moment you pair it with an SPF claim. The ingredient identity is identical. The concentration may be identical. The only variable that crosses the boundary is the claim on the label. A product with 7.5% Octinoxate and no SPF claim is a cosmetic. The same product with 7.5% Octinoxate and the claim “SPF 15” is an OTC drug regulated under the sunscreen monograph. It requires a Drug Facts panel, NDA exemption compliance, and manufacturing under pharmaceutical GMP.
Japan's quasi-drug system has a different but equally claim-driven structure. Tranexamic Acid, Arbutin, and Kojic Acid are cosmetic ingredients without whitening claims. When positioned for whitening (美白) at defined concentrations, they require quasi-drug registration. The active ingredient concentration and the intended effect together determine the classification, not the concentration alone.
Design principle
Our job is to surface the information. Acting on it is the formulator's decision. We never block a formulation based on regulatory alerts: we flag, explain, and cite the relevant regulation. Whether to proceed, reformulate, or adjust claims is always the formulator's call.
9 boundary markets — 82 thresholds
Each threshold is classified by type, tied to the relevant regulation and article, and linked to the specific ingredient or claim category it applies to.
| Market | Thresholds | Coverage |
|---|---|---|
| US (FDA) | 34 | OTC monograph triggers, concentration limits Sunscreen actives, anti-dandruff, anti-acne, antiperspirant, fluoride toothpaste monographs. Concentration and claim-based triggers. |
| Japan (MHLW) | 10 | Quasi-drug (医薬部外品) classification triggers Active ingredients and concentrations triggering quasi-drug classification across whitening, hair growth, medicated cosmetic, and anti-perspiration categories. |
| India (CDSCO/BIS) | 9 | IS 4707 restrictions, drug schedule triggers Drugs and Cosmetics Act Schedule M, BIS IS 4707 prohibited and restricted lists, drug schedule boundary triggers. |
| South Korea (MFDS) | 8 | Functional cosmetic (기능성화장품) registration Whitening, UV protection, hair loss prevention, and wrinkle improvement actives at concentrations requiring functional cosmetic registration. |
| Canada (Health Canada) | 6 | NHP/drug boundary triggers Natural Health Products Regulations boundary: ingredients and claims that move a product from cosmetic to NHP or drug requiring a DIN or NPN. |
| China (NMPA) | 6 | Special cosmetic (特殊化妆品) classification Sunscreen, hair dye, hair perm, deodorant, and skin whitening actives and concentrations triggering special cosmetic registration. |
| Brazil (ANVISA) | 4 | Grade 2 cosmetic triggers RDC 752 Grade 2 classification: ingredients and intended uses requiring ANVISA pre-market notification or registration. |
| Taiwan (TFDA) | 4 | Specific-use cosmetic classification Arbutin and hydroquinone-boundary actives and concentrations triggering specific-use cosmetic (含藥化粧品) registration under the Cosmetic Hygiene and Safety Act. |
| Australia (TGA) | 1 | Therapeutic goods triggers Therapeutic Goods Act boundary: active ingredients and concentrations requiring inclusion on the ARTG as a listed or registered medicine. |
5 threshold types
Not all drug-cosmetic boundaries work the same way. We classify every threshold by type — because the formulator response to a concentration trigger is completely different from the response to a claim trigger or a special-registration requirement.
Concentration
Triggers when an ingredient exceeds a market-specific maximum concentration. The most straightforward threshold type.
Example
Salicylic Acid > 2% in the US = OTC drug (acne monograph). Salicylic Acid ≤ 2% = cosmetic. The ingredient is identical. Only the concentration changes the classification.
Claim
Triggers when a claim category is present, regardless of ingredient concentration. This is the threshold type most formulators miss — and why a lookup table fails.
Example
In the US, any sunscreen active (Octinoxate, Zinc Oxide, Avobenzone) in a product is cosmetic. Add an SPF claim = OTC drug. The claim, not the ingredient or concentration, crosses the line.
Concentration + Claim
Requires both conditions simultaneously: ingredient above threshold AND a specific claim category. Both must be present to trigger.
Example
Benzoyl Peroxide above 2.5% and an acne treatment claim in the US = OTC drug. Benzoyl Peroxide at 1% with no acne claim = cosmetic exfoliant.
Always Drug
Ingredient is classified as a drug or pharmaceutical substance in that market regardless of intended use, concentration, or claims.
Example
Minoxidil in the EU — classified as a medicinal product regardless of use. Any cosmetic formulation containing Minoxidil triggers a Critical alert for EU.
Special Registration
Ingredient presence (sometimes above a threshold) triggers a mandatory registration or notification pathway. The product can proceed, but not as a standard cosmetic without filing.
Example
Tranexamic Acid in Japan = quasi-drug registration required for whitening claims. Niacinamide in Korea above threshold = functional cosmetic registration required.
Alert severity levels
Each alert carries one of three severity levels. Severity reflects the nature of the regulatory issue, not the formulator's risk appetite. That judgment remains theirs.
ingredient_banalways_drugIngredient is banned as a cosmetic, or is always classified as a drug in this market. Presence alone triggers the alert, no concentration or claim required.
- Tretinoin in EU or US (prescription pharmaceutical)
- Hydroquinone in EU cosmetics (Annex II ban)
- Minoxidil in EU (medicinal product regardless of use)
concentrationclaimconcentration_and_claimConcentration or claim combination crosses into drug, quasi-drug, or functional cosmetic territory. The ingredient is permitted as a cosmetic under different conditions, but the current combination requires regulatory action.
- Salicylic Acid > 2% with acne claim in US (OTC drug monograph)
- SPF claim + any sunscreen active in US (OTC drug monograph)
- Niacinamide above threshold with whitening claim in Korea (functional cosmetic)
special_registrationIngredient presence triggers a mandatory registration or notification pathway. The product can proceed to market, but it requires a specific regulatory filing before launch.
- Tranexamic Acid in Japan with whitening claim (quasi-drug registration required)
- Kojic Acid in Japan at threshold concentration
- UV-filtering actives in China (special cosmetic — NMPA registration required)
How it integrates into the formulation workflow
Regulatory intelligence isn't a standalone lookup; it runs at every stage of the formulation workflow. By the time a report is generated, every ingredient has already been checked against every target market multiple times.
Brief building
As you add ingredients, concentrations, and claims to your brief, the system checks every ingredient against every selected market against every applicable claim category. Checks run with a 500ms debounce. Drug-cosmetic boundary alerts appear inline before you submit the brief, catching boundary issues before a formulation is generated, not after.
Formulation generation
During generation, ingredient concentrations are pre-validated against per-market restricted ingredient limits. Ingredients approaching or exceeding market-specific concentration ceilings are flagged during the generation pass; concentrations are adjusted or alternatives are surfaced. Prohibited ingredients are excluded from generated formulations for the relevant markets entirely.
4-sweep validation
After generation, every formulation runs a four-sweep regulatory validation: prohibited ingredient check across all target markets, restricted ingredient concentration check, drug-cosmetic boundary alert check (ingredient × concentration × claim), and special registration trigger check. Each sweep produces structured findings, not free-text warnings.
Report output
Every generated report includes a dedicated regulatory section: per-ingredient regulatory traffic lights across all target markets (green = permitted, amber = restricted with conditions, red = prohibited or boundary alert), boundary alerts with regulatory citations, and special registration flags with the applicable pathway. All findings are traceable to the specific regulation, article, and annex.
Regulatory coverage expands as new threshold data is extracted and validated. Market additions and threshold updates are logged with the date they were detected and, where the source states it, their effective date, so formulators can see when a boundary changed and what triggered the change.
Last updated: July 2026